An Israeli company has started final-stage tests of its oral insulin, bidding to become the first to make the product available on the international market.
The product started phase three trials under the US Food and Drug Administration in California on Monday, after 14 years of development. If all goes well, Oramed Pharmaceuticals says it expects type 2 diabetics to start taking its pills in just over three years, followed by type 1 diabetics after further testing.
“This has the potential to improve lives of hundreds of millions of diabetics worldwide,” Oramed CEO Nadav Kidron told The Times of Israel. “And by improving treatment it can reduce complications and, in turn, reduce the cost of treating diabetics.”
He said that the dosing tech that is being used for insulin has “very significant” potential for the creation of oral versions of other medical injections.
An Indian company, Biocon, is also working on oral insulin, but unlike Oramed it has not started advanced trials with the FDA, which is seen as the main path to the international market.
Oramed has big money behind its innovation: In 2015 it signed a $50 million licensing and investment deal with China’s Hefei Life Science & Technology Park Investments and Development Co. (HLST), a subsidiary of Chinese pharma giant Sinopharm, for the rights to its oral insulin capsule in China.
Kidron said his product transports insulin to where the body can make the best use of it — the liver, rather than the bloodstream, where it is currently delivered.
“One benefit of oral insulin is that we overcome the fear of the needle, but, more importantly, the insulin is being delivered directly to the liver.
“By taking it to the liver we are stopping the excessive production of glucose in the place where the production actually happens. Usually, injections go into the bloodstream and deal with glucose there instead of stopping production in the liver, its source.”
Pills will become a major source of insulin, he predicted, but they won’t replace injections entirely, as type 1 diabetics will still need to inject some of their doses.
He said that as well as helping insulin-dependent diabetics, it will allow doctors who are hesitant to start injections to prescribe occasional insulin via pills.
The direct delivery minimizes side effects, especially weight gain which is the bane of many diabetics’ lives, Kidron said.
“So far in the phases of trials conducted to date, we [have] not seen the weight gain that is associated with injected insulin,” he commented.
In Phase 2b trials, the oral insulin showed a statistically significant lowering of hemoglobin A1c levels, a key marker of diabetes, without serious adverse events or weight gain.
The initial technology was developed at Hadassah Medical Center in Jerusalem — by Kidron’s mother, biochemist Miriam Kidron, today Oramed’s chief scientific officer. The Nobel laureate and Israel Prize-winning biochemist Avram Hershko is one of the company’s scientific advisers.
The big obstacle to oral insulin has been that the gut would harm it before it reaches the liver. Oramed’s tech overcomes this with a specially-coated pill that stays whole and releases the insulin as it gets to the liver.
“The fact we’re able to get the pill to the liver, which is exactly where the insulin is needed, is a major achievement,” said Kidron. “For nearly 100 years the world has looked for ways to be able to give insulin orally. This technology could be a real game-changer in how we treat diabetes.”